QMS

Date : 23 Oct 2025

Location :

Bangalore, KA, IN, 560099

Division : Manufacturing Services

Perform / ensure regular facility walkthroughs and raise a work orders if applicable or communicate to respective area supervisor.

• Participate / facilitate , external audits / internal audits / self-inspection for Bio-Pharmaceutical Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment.
• Track the facility walkthrough checklist and facilitate timely closure of identified action plan.
• Participate / track / ensure timely proposal and implementation of appropriate CAPA for audit findings, gaps identified in risk assessments, investigations and implement CAPA to prevent reoccurrence.
• Review of executed GMP records within the manufacturing facility (Batch Records, Equipment Usage Logbooks etc.) to ensure adherence to Good Documentation Practice(s), Data Integrity and compliance with approved Standard Operating Procedures.
• Perform and support timely preparation, review and approval of GMP documentations for Biologics Operations. o Standard Operating Procedures (EOP, IOP and SOP) o Protocols and Reports o Any other GMP relevant documentation
• Participate in batch dispatch activity for technical batches.
• Conduct and / or support training on SOPs (including

vernacular language), protocols and on-the-job activities.

Skills Required

data integrity, Risk Management